Study on Quality Standard of Jingyuan Capsules / 中国药房

ABSTRACT

OBJECTIVE:To establish the quality standard of Jingyuan capsule. METHODS:TLC was used for qualitative iden-tification of Epimedium brevicornu,Pseudostellaria heterophylla and Fallopia multiflora in the preparation. HPLC method was used to determine the content of icariin. The determination was performed on Odyssil C18 column with mobile phase consisting of acetoni-trile-water(28:72,V/V)at the flow rate of 1.0 mL/min. The detection wavelength was set at 270 nm,and the column temperature was 30 ℃. The sample size was 10 μL. The contents of polysaccharides was determined by phenol-sulfuric method. RESULTS:TCL spots of E. brevicornu,P. heterophylla and F. multiflora were clear and well separated without interference from negative con-trol. The linear range of icariin ranged 0.027-0.135 mg/mL(r=0.9999);RSDs of precision,stability and repeatability test were all lower than 2.0%. The recoveries were 97.87%-101.94%(RSD=1.47%,n=9). The linear range of glucose ranged 0.056-0.121 mg/mL(r=0.9995),and RSDs of precision,stability and repeatability tests were all lower than 2.0%. The recoveries were 99.37%-100.38%(RSD=0.36%,n=6). CONCLUSIONS:The established standard can be used for the quality control of Jingyuan capsule.